Protocol summary

Study aim
Comparison of two enhanced and conventional recovery protocols on short- and mid-term outcomes of women undergoing laparoscopic surgery.
Design
This is a double blind randomized clinical trial study. Patients will be randomly divided using a random number table into two groups(intervention and control).
Settings and conduct
This is a double blind randomized clinical trial study. Patients referred to Hazrat Rasool Akram Hospital in 2019-2020 according to inclusion criteria will be enrolled to the study.
Participants/Inclusion and exclusion criteria
In this study patients who are candidates laparoscopic for gynecological surgery which not being anemia, not being infected, do not suffer from underlying disease, and BMI<25.5 will be enrolled to the stud. Exclusion criteria will be included: conversion from laparoscopic surgery to laparotomy, more interventions (blood transfusions,.....), occurrence of unpredictable complications during surgery, the unwillingness of women to continue the study.
Intervention groups
The intervention group will be patients who were laparoscopic candidates for gynecological surgery and will receive an enhanced recovery. The intervention group will be patients who were laparoscopic candidates for gynecological surgery and will receive a conventional recovery.
Main outcome variables
The primary outcome in this study would be pain score, need for analgesia, fever, nausea and vomiting, diarrhea, postoperative infection, length of hospital stay, hemoglobin changes, bleeding rate, resumption of bowel activity.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191123045476N1
Registration date: 2020-05-21, 1399/03/01
Registration timing: retrospective

Last update: 2020-05-21, 1399/03/01
Update count: 0
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Samaneh Rokhgireh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
rokhgireh.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study between enhanced and conventional recovery on postoperative outcomes in women candidates for laparoscopic surgery.
Public title
Comparative study between enhanced and conventional recovery on postoperative outcomes in women candidates for laparoscopic surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not being anemia Not being infected Do not suffer from underlying disease (heart, lung, gastrointestinal, thyroid, nervous, mental, etc.). BMI<25.5
Exclusion criteria:
Conversion from laparoscopic surgery to laparotomy The unwillingness of women to continue the study. More interventions (blood transfusions,.....) Occurrence of unpredictable complications during surgery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the patients will be randomly assigned to one of two groups by a computer-generated random table block of size 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the principal investigator and data analyser will be kept blind to the assigning groups of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1986663311
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
IR.IUMS.REC.1398.724

Health conditions studied

1

Description of health condition studied
Laparoscopic gynecological surgery
ICD-10 code
Z53.31
ICD-10 code description
Laparoscopic surgical procedure converted to open procedure

Primary outcomes

1

Description
Pain score
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

2

Description
Need for analgesia
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

3

Description
Fever
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

4

Description
nausea and vomiting
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

5

Description
Diarrhea
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

6

Description
Postoperative infection,
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

7

Description
Length of hospital stay
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

8

Description
Hemoglobin changes
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

9

Description
Bleeding volume
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

10

Description
Resumption of bowel activity
Timepoint
After surgery
Method of measurement
Questionnaire and medical records

Secondary outcomes

1

Description
Postoperative infection
Timepoint
2 weeks after surgery
Method of measurement
Questionnaire

2

Description
Return to normal activity
Timepoint
2 weeks after surgery
Method of measurement
Questionnaire

3

Description
Return to work
Timepoint
2 weeks after surgery
Method of measurement
Questionnaire

4

Description
Hospital readmission.
Timepoint
2 weeks after surgery
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group will be 80 patients who were candidates laparoscopic for gynecological surgery. Perioperatively, this group will be managed according to Enhanced Recovery After Surgery (ERAS) protocols. The basic principles of ERAS include attention to the following: preoperative counseling and nutritional strategies, including avoidance of prolonged perioperative fasting, perioperative considerations, including a focus on regional anesthetic and nonopiod analgesic approaches, fluid balance, and maintenance of norothermia, and promotion of postoperative recovery strategies, including early mobilization and appropriate thromboprophylaxia.
Category
Treatment - Surgery

2

Description
Control group will be 80 patients who were candidates laparoscopic for gynecological surgery. Perioperatively, this group will be managed according to conventional hospital management protocols.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Samaneh Rokhgireh
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 9283
Email
s.rokhgireh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abas Motavalian
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
13670
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Email
s.rokhgireh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Email
s.rokhgireh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Email
s.rokhgireh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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