TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

Not Applicable

• Conditions: Ulcerative Colitis; Ileal Pouch; Postoperative Complications
• Interventions: Procedure: TAMIS-IPAA; Procedure: Lap-IPAA

• Registration Number: NCT03536988
• Lead Sponsor: Jinling Hospital, China

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.

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 Timeline

• Status Verified: 2018-01
• Study Start: 2018-04-12
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Last Update Submitted: 2018-05-15
• Study First Posted: 2018-05-25
• Last Update Posted: 2018-05-25
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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.

Exclusion Criteria

• A contraindication for minimally invasive surgery or TAMIS surgery
• Ileus or peritonitis
• Previous surgery in rectum
• Pregnancy
• Carcinogenesis of rectum, dysplasia or stricture of ATZ, or planned mucosectomy
• Patients with planned permnant ileostomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAMIS-IPAA	TAMIS-IPAA	In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.
Lap-IPAA	Lap-IPAA	In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	Day 30	Postoperative complcations were documented using comprehensive complication index(CCI)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China