CompletedNot Applicable

Study of Unsutured Versus Sutured Closure of Rectal Defects After Rectal Lesion Excisions Using Transanal Endoscopic Microsurgery

Canada50 participantsStarted 2012-03

Plain-language summary

Transanal Endoscopic Microsurgery (TEM) is a minimally invasive technique used to remove rectal tumours. After the tumour has been removed from the rectum, the surgeon has a choice to close the defect or leave the defect open and naturally close. Currently, both options are accepted as standard care. Leaving the defect open to close naturally has some possible advantages, including shortened operation time and similar rates of postoperative complications. However, there is some concern that not surgically closing the defect may lead to more postoperative pain and delay in recovery. The study will be a double blind randomized controlled trial and determine whether patients who have rectal wall defect sutured closed have less post-operative pain compared to patients whose defect is left open.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patients must be over 18 years old with a rectal lesion \< 12cm from the anal verge (as measured by rigid sigmoidoscopy) and less than half the circumference of the rectal lumen. The patient must provide informed consent for TEM and inclusion in the trial. Exclusion Criteria: * The surgeon decides to convert to laparotomy or conventional TAE for any reason during tumor excision. * The surgeon judges that the rectal defect is not appropriate for suturing (e.g. too large) or to be left unsutured (e.g. entry into peritoneal cavity) * The patient is currently treated for chronic pain prior to surgery, has a known bleeding diathesis (e.g. warfarin treatment, hemophilia, etc) or is immunosuppressed (e.g. Prednisone, HIV,etc)

What they're measuring

Postoperative Pain

Timeframe: 1day after surgery

Trial details

NCT IDNCT01465945

SponsorDr. Carl J Brown

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-10