TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis
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|ClinicalTrials.gov Identifier: NCT03536988|
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Postoperative Complications Ileal Pouch||Procedure: TAMIS-IPAA Procedure: Lap-IPAA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial|
|Actual Study Start Date :||April 12, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.
In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
Active Comparator: Lap-IPAA
In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.
In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.
- Postoperative Complications [ Time Frame: Day 30 ]Postoperative complcations were documented using comprehensive complication index(CCI)
- Duration of operation [ Time Frame: 24 Hr ]The duration of operation will be documented in minutes, from skin incision to dress coverage
- The incidence of pouch extension [ Time Frame: 24 Hr ]the need to extend the length of pouch during operation
- Intraoperative complications [ Time Frame: 24 Hr ]Including anastomotic burst, iatrogenic injury
- Estimated blood loss [ Time Frame: 24 Hr ]in mLs during surgery
- Postoperative anastmotic leakage [ Time Frame: Day 90 ]Anastomotic leakage was defined as any defect at the anastomotic site confirmed by imaging or during surgical re-intervention, and was categorised according to the impact on clinical management [A, B, C]. Grade A leaks had minimal to no clinical impact on the patient's postoperative course, requiring antibiotics at the most. Grade B leaks required active intervention such as radiological placement of a pelvic drain or transanal lavage. Grade C leaks required re-operation, mostly because the patient was not defunctioned.
- Time to GI-2 recovery [ Time Frame: Day 90 ]Time to GI-2 recovery, a composite end point of the later of upper (first toleration of solid food) and lower (first bowel movement) GI function.
- Postoperative length of hospital stay [ Time Frame: Day 90 ]in days
- Overall cost of treatment [ Time Frame: up to 1 year ]In Chinese Yuan (CNY)
- Remaining length of anal mucosa. [ Time Frame: 24 Hr ]The mean lenght of four quadrant during pouchoscopy 2 months after opertion, the length was calculated from the dental line to the anastomotic site.
- The incidence of cuffitis and pouchitis [ Time Frame: up to 1 year ]Pouchitis is defined as inflammatory condition of the ileal pouch reservoir, while cuffitis is defined as the inflammatory condition of the remnant rectal cuff.
- Postoperative quality of life [ Time Frame: up to 1 year ]Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536988
|Contact: Jianfeng Gong, MDemail@example.com|
|Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: Jianfeng Gong, MD +86-25-80860036 firstname.lastname@example.org|
|Principal Investigator:||Jianfeng Gong||Jinling Hospital, China|