Objective: efficacy and safety of stapled hemorrhodopexy on incontinence.
Design: observational model, cohort
Time Perspective: Prospective
Setting and conduct: Patients will be assessed for incontinence 3 month after stapled hemorrhoidopexy by anal manometry and Wexner score.
Inclusion criteria: patients undergoing stapled hemorrhodopexy for rectal prolapse and/or hemorrhoid grade III or IV
Exclusion criteria: younger than 18 or experiencing more than 80 times history of incontinence, diabetic mellitus and neurological disease.
Intervention: patients will undergo stapled hemorrhodopexy.
Main outcome measures: incontinence, anal manometry and Wexner score, bleeding, time of operation, site of stapler line.
Hemorrhoids are a worldwide benign anorectal disease. Stapled hemorrhoidopexy for third and forth degree hemorrhoids and prolapse has been widely used since 1998. This method has less pain and discharge in comparison to previous traditional methods. Yet, stapled hemooroidopexy have complications such as bleeding, incontinence, stricture, fistula, and rupture. We will performe an analysis of a prospectivedata set of all patients undergoing stapled hemooroidopexy in our patients. Patients will be specifically assessed for complications of incontinence 3 months after the operation.
Anal manometry and Wexner score was determined before and 3 months after the operation.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015101324504N1
Registration date:2016-06-18, 1395/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Seyed Vahid Hosseini
Name of organization / entity
Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1453
Email address
hoseiniv@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the impact of stapled hemorrhodopexy on stool continence in patients with hemorrhoids
Public title
Assessing the impact of stapled hemorrhodopexy on stool continence in patients with hemorrhoids
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 and lesser than 80; patients with hemorrhoids grade 3 or 4; patients with prolapsed and/or hemorrhoids grade 3 or 4 Exclusion criteria: Patients with fecal incontinence; patients with diabetes; patients with neurological disease.
Age
From 17 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of Medical Sciences, Shiraz, Iran
Street address
Vice-chancellor for research of Shiraz university of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2015-09-13, 1394/06/22
Ethics committee reference number
IR.sums.REC.1394.106
Health conditions studied
1
Description of health condition studied
Fecal incontenence
ICD-10 code
R15
ICD-10 code description
Faecal incontinence
Primary outcomes
1
Description
Fecal incontinence
Timepoint
Before surgery and 3 months after surgery
Method of measurement
with Manometry and Wexner score.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients with inclusion criteria will be evaluated for manometry and Wexner score before surgery. To evaluate the anal function, a
validated Wexner incontinence scale score system (total incontinence score 0: best and 20: worst) and anal manometric indices will be measured 1 day before the surgery and 3 months after the operation. The Wexner scale was described by Wexner and Jorge and consisted of items about frequency of gas and fecal incontinence. Anal manometric measures and Wexner scores will be compared pre- and postoperatively.
For doing anorectal manometry, the patient will be positioned in left lateral decubitus with knees flexed. For anal manometry, a Sphinctrometer system (MSM Promedico GmbH) will be used. After calibration, a probe will be introduced into the rectal ampulla up to 6 cm from the anal verge. Anal resting Pressure (ARD), anal maximum squeezing pressure (AMD), and Mean pressure will be calculated.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari hospital, Shiraz University of Medical Sciences