TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

Sponsor

Jinling Hospital, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT03536988

Collaborator

(none)

Enrollment

Location

Arms

31.7

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this RCT is to compare the postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Postoperative Complications Ileal Pouch	Procedure: TAMIS-IPAA Procedure: Lap-IPAA	N/A

Detailed Description

Theoritically, the advantge of TAMIS surgery over traditional trans-abdominal IPAA surgery incudes shorter operation time due to simulatous surgery transanlly and transabdominally, reduced operative difficulty in narrow male pelvis, less retained rectal cuff and less "dog-ear" formation. However, its adgange has not been proven in prospecitve randomized trials. The aim of current study is to compare the short and long-term postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Apr 12, 2018

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAMIS-IPAA In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.	Procedure: TAMIS-IPAA 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.	Procedure: Lap-IPAA In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.

Arm

Intervention/Treatment

Experimental: TAMIS-IPAA

In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.

Procedure: TAMIS-IPAA

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.

Procedure: Lap-IPAA

In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.

Outcome Measures

Primary Outcome Measures

Postoperative Complications [Day 30]
Postoperative complcations were documented using comprehensive complication index(CCI)

Secondary Outcome Measures

Duration of operation [24 Hr]
The duration of operation will be documented in minutes, from skin incision to dress coverage
The incidence of pouch extension [24 Hr]
the need to extend the length of pouch during operation
Intraoperative complications [24 Hr]
Including anastomotic burst, iatrogenic injury
Estimated blood loss [24 Hr]
in mLs during surgery
Postoperative anastmotic leakage [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 [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 [Day 90]
in days
Overall cost of treatment [up to 1 year]
In Chinese Yuan (CNY)
Remaining length of anal mucosa. [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 [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 [up to 1 year]
Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clincially and pathologically proven ulcerative colitis
Aged 18-75 years
Patients who will undergo proctectomy and IPAA surgery, incuding the first stage of two-stage surgery, or the second stage of three-stage or modified two-stage surgery
Elective surgery
Informed constent obtained.