Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439907
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2007-02-23
Brief Title:
Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
Sponsor:
Helse Stavanger HF
Organization:
Helse Stavanger HF
Study Overview
Official Title:
A Prospective Randomized Study Comparing the Outcome of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rupture of the external anal sphincter occurs in about 4 percent of deliveries It is not clear from other studies whether the results concerning anal function eg fecal continence are better with the overlap repair or end-to-end repair of the injured muscle The researchers randomize women at birth to either overlap or end-to-end when the injury is recognized and examine them one year later with special anal physiologic examinations and a validated questionnaire The hypothesis is that the overlap technique is superior
Detailed Description:
Rupture of the external anal sphincter occurs in about 4 percent of deliveries in our department It is not clear from other studies whether the results concerning anal function are better with the overlap repair or end-to-end repair of the injured muscle Our routine has been to perform an end-to-end repair though anal surgeons in the setting of a secondary repair prefer the overlap method Former studies when the repair was performed by highly skilled operators have indicated that the overlap method is better
We wanted to compare the two methods through a RCT with the end-points examination results after one year addressing endoanal sonography findings anal manometric results and continence score evaluated by a Weksner score questionnaire Our study is performed in the routine clinical setting The patients are recruited to the study during delivery when the injury is recognized When she has given her informed consent she is randomized to one of the two operation methods The operation is performed by the consultant obstetrician on call or the resident supervised by the consultant The proctologist who performs the anal manometry and sonography after one year is blinded to the surgical method
We plan to include approximately 160 patients at one center In our center we have about 4500 deliveries per year
We wanted to compare the two methods through a RCT with the end-points examination results after one year addressing endoanal sonography findings anal manometric results and continence score evaluated by a Weksner score questionnaire Our study is performed in the routine clinical setting The patients are recruited to the study during delivery when the injury is recognized When she has given her informed consent she is randomized to one of the two operation methods The operation is performed by the consultant obstetrician on call or the resident supervised by the consultant The proctologist who performs the anal manometry and sonography after one year is blinded to the surgical method
We plan to include approximately 160 patients at one center In our center we have about 4500 deliveries per year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None