Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAMIS-IPAA | Experimental | In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed. |
|
| Lap-IPAA | Active Comparator | In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAMIS-IPAA | Procedure | In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | Postoperative complcations were documented using comprehensive complication index(CCI) | Day 30 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfeng Gong, MD | Contact | +86-25-80860036 | gongjianfeng@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianfeng Gong | Jinling Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210000 | China |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lap-IPAA | Procedure | In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed. |
|
| 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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |