Protocol summary
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Study aim
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Determining the effect of drain in pain control after laparoscopic ovarian cystectomy surgery in women at Afzalipur Hospital, Kerman.
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Design
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A clinical trial with a control group, with parallel groups, a blind strain, randomized, on nodes of 130 intervention and control people, rand function of Excel software was used for randomization.
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Settings and conduct
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This study will be conducted in Afzalipur Hospital, Kerman, on patients with ovarian cysts. After randomizing the patients, the patient group will be determined using a sealed envelope, and the patients will be blinded to the study
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Participants/Inclusion and exclusion criteria
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Women aged 18 to 62 without any comorbidities who will undergo cystectomy surgery for ovarian cysts in Afzalipur Hospital and have no complications during the operation and are fully awake will be included in the study after obtaining written informed consent.
People with a history of abdominal and thoracic surgery, psychiatric patients, those with chronic pain in the abdomen, pelvis, systemic disease, fallopian tube abscess (before or during surgery), shoulder pain and trauma, and patients whose laparoscopic surgery is changed to laparotomy and Patients who require a drain due to organ damage, bleeding or infection will be excluded from the study.
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Intervention groups
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260 women aged 18 to 62 who are candidates for laparoscopic surgery for ovarian cystectomy in Afzalipur Hospital, Kerman, will undergo surgery after being randomly assigned to control and intervention groups of 130 people and after the end of the surgery in the intervention group (with a drain), the Hemovac type drain is placed in place for 24 hours and the drain is removed after 24 hours.In the group without drain, the surgical procedures are completely similar.But in the end, the surgery will end without the insertion of a drain.
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Main outcome variables
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Patient pain score after surgery
General information
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Reason for update
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260 patients were examined.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230130057275N1
Registration date:
2023-03-14, 1401/12/23
Registration timing:
registered_while_recruiting
Last update:
2023-08-09, 1402/05/18
Update count:
1
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Registration date
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2023-03-14, 1401/12/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-22, 1401/11/02
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Expected recruitment end date
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2023-08-23, 1402/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effectiveness of drain in pain control in women who need laparoscopic ovarian cystectomy surgery in two groups with drain and without drain
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Public title
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Investigating the effect of drain in pain control after laparoscopic cystectomy surgery in women referred to Afzalipur Hospital, Kerman
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women aged 18 to 62 without any comorbidities who will undergo laparoscopic ovarian (LOC) for ovarian cysts from January to March 1401 in Afzalipur University Hospital and have no complications during the operation will be studied
Full consciousness
providing informed written consent
not using analgesic before surgery
Exclusion criteria:
History of abdominal and thoracic surgery
psychiatric patients
those with chronic pain in the abdomen, pelvis, systemic disease, fallopian tube abscess (before or during surgery), shoulder pain and trauma
Patients whose laparoscopic surgery is changed to laparotomy
Patients who need a drain due to organ damage, bleeding or infection will be excluded from the study
Patients who develop complications (fever, bleeding, infection at the incision site, atelectasis, subcutaneous emphysema) will also be excluded from the pain intensity study and will be studied only to compare and determine the effect of the drain on the complications
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Age
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From 18 years old to 62 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
260
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The sample number of 260 people will be selected as available and will be randomly divided into two groups of 130 people using random list software. Informed consent will be obtained from all patients of both groups. After the research is approved by the ethics committee, the subjects will be divided into two groups completely randomly using envelopes. For this purpose, envelopes are considered for the number of patients and the code related to the study group is placed inside the envelopes, then with each patient's visit, a specific code is assigned to each patient and his code is written on a random envelope. to be The envelope for each person will be opened at the beginning of the surgery, and based on that, each person will be assigned to the desired group. Randomization will be done by someone outside the research, this person and no other person will be aware of the contents inside the envelopes. Due to the nature of the study, it is not possible to blind the interventionist, but the surgeon was not aware of the patient group until the end of the study, and in order to reduce and minimize the bias, other information will be collected by another researcher after the surgery.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Randomization will be done by someone outside the research, this person and no other person will be aware of the contents inside the envelopes. Due to the nature of the study, it is not possible to blind the interventionist, but the surgeon was not aware of the patient group until the end of the study, and in order to reduce and minimize the bias, other information will be collected by another researcher after the surgery.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-01-21, 1401/11/01
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Ethics committee reference number
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IR.KMU.AH.REC.1401.248
Health conditions studied
1
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Description of health condition studied
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Ovarian cyst
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ICD-10 code
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N83.29
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ICD-10 code description
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Other ovarian cysts
Primary outcomes
1
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Description
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The primary outcome of the study is the pain score, which is collected through the VAS questionnaire.
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Timepoint
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VAS pain questionnaire will be measured at 4 hours, 12 hours, 24 hours, 42 hours and 72 hours after surgery.
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Method of measurement
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Visual Analog Scale for Pain (VAS )
Secondary outcomes
1
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Description
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Time to work the bowels
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Timepoint
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Last hours after surgery
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Method of measurement
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data collection form through patient declaration
2
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Description
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Days of stay in the hospitalization
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Timepoint
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hospitalization days after surgery
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Method of measurement
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Investigation of Medical Record
3
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Description
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location of pain
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Timepoint
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4 hours, 12 hours, 24 hours, 42 hours and 72 hours after surgery
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Method of measurement
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History and interview with the patient and physical examination
Intervention groups
1
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Description
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Intervention group (with drain): Patients will be anesthetized before the start of laparoscopy. The patients will be operated by a surgical team. All patients will be given intravenous cefazolin 1 gram as a prophylactic antibiotic after induction of general anesthesia. General anesthesia will be performed using common anesthetic drugs used in Afzalipur Kerman Hospital. Laparoscopic surgery will be performed using carbon dioxide gas and three ports or incisions will be made as follows. One 10.5 mm incision below the umbilical cord to enter the telescope and two 5.5 mm incisions through the outer edge of the rectum to enter the surgical instrument. CO2 gas enters the peritoneum with an initial pressure of 12 to 16 mm Hg. After the end of the surgery in this group, before closing the skin and suture of the surgical site, a Hemovac type drain was inserted through a 5.5 mm side incision without any additional incision and placed in a suitable place in the surgical site. After that, the rest of the incision is sutured with surgical thread. The drain is placed in place for 24 hours and after that, the drain will be removed.
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Category
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Treatment - Surgery
2
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Description
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Control group (without drain): Patients will be operated by a surgical team. All patients will be given intravenous cefazolin 1 gram as a prophylactic antibiotic after induction of general anesthesia. General anesthesia will be performed using common anesthetic drugs used in Afzalipur Kerman Hospital. Laparoscopic surgery will be performed using carbon dioxide gas and three ports or incisions will be made as follows. One 10.5 mm incision below the umbilical cord to enter the telescope and two 5.5 mm incisions through the outer edge of the rectum to enter the surgical instrument. CO2 gas enters the peritoneum with an initial pressure of 12 to 16 mm Hg. After the end of the surgery in the control group, the surgery will be completed without the insertion of the drain.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable