TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

Study Overview
=================
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.

Official Title
-----------------
Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial

Conditions
-----------------
Ulcerative Colitis, Postoperative Complications, Ileal Pouch

Intervention / Treatment
-----------------
* Procedure: TAMIS-IPAA
* Procedure: Lap-IPAA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAMIS-IPAA<br>In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed. | Procedure: TAMIS-IPAA<br>* In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.<br>|
| Active Comparator: Lap-IPAA<br>In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed. | Procedure: Lap-IPAA<br>* In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | Postoperative complcations were documented using comprehensive complication index(CCI) | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation | The duration of operation will be documented in minutes, from skin incision to dress coverage | 24 Hr | 
| The incidence of pouch extension | the need to extend the length of pouch during operation | 24 Hr | 
| Intraoperative complications | Including anastomotic burst, iatrogenic injury | 24 Hr | 
| Estimated blood loss | in mLs during surgery | 24 Hr | 
| Postoperative anastmotic leakage | 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. | Day 90 | 
| Time to GI-2 recovery | 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. | Day 90 | 
| Postoperative length of hospital stay | in days | Day 90 | 
| Overall cost of treatment | In Chinese Yuan (CNY) | up to 1 year | 
| Remaining length of anal mucosa. | The mean lenght of four quadrant during pouchoscopy 2 months after opertion, the length was calculated from the dental line to the anastomotic site. | 24 Hr | 
| The incidence of cuffitis and pouchitis | Pouchitis is defined as inflammatory condition of the ileal pouch reservoir, while cuffitis is defined as the inflammatory condition of the remnant rectal cuff. | up to 1 year | 
| Postoperative quality of life | Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q) | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ileal pouch anal anastomosis, Transanal Minimally Invasive Surgery, Ulcerative Colitiis, Postoperative Outcome