Ileal Pouch, Postoperative Complications, Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitiis, Ileal pouch anal anastomosis, Transanal Minimally Invasive Surgery, Postoperative Outcome
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.
Interventions
PROCEDURETAMIS-IPAA
In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
PROCEDURELap-IPAA
In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | Day 30 | Postoperative complcations were documented using comprehensive complication index(CCI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Duration of operation | 24 Hr | The duration of operation will be documented in minutes, from skin incision to dress coverage |
| 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) |
| Postoperative length of hospital stay | Day 90 | in days |
Countries
China
Contacts
Primary ContactJianfeng Gong, MD
Outcome results
None listed