Ileostomy; Complications
Conditions
Keywords
ileostomy, complications, NOSES, stoma suture
Brief summary
Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the treatment of rectal cancer because of its postoperative non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics. Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to divert feces and protect the anastomosis. For such patients, rectal anterior resection surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also realizing the absence of additional abdominal incision. However, this procedure is prone to stoma infection and has a high complication rate (20-40%), which limits the popularization of NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure method (Dumpling Suture Method), which reduces the size of the incision by folding the suture to achieve the effect of hiding the skin incision and reduce stoma infection. The study aimed to introduce the Dumpling suture method of protective loop ileostomy in laparoscopic anterior resection and compare this new method with the traditional method. From August 1st 2019 to August 1st 2023, 22 cases of the new procedure were completed in our center, and 30 patients with stoma closure by the traditional method were included in the same period for control purposes. A retrospective analysis was conducted on 52 patients in the study center, and the intraoperative details and postoperative outcomes of the two groups were measured.
Interventions
Suturing of ileostomy using Dumpling suture method
Suturing of ileostomy using Traditional suture method
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. All patients underwent successful laparoscopic anterior rectal resection plus protective loop ileostomy with specimen extraction through stoma incision; 2. All patients were pathologically diagnosed with rectal carcinoma or ulcerative colitis; 3. Patients aged 18 - 80 years 4. ASA (American Society of Anesthesiologists) classification ≤ grade 3. 5. Patient participate voluntarily and sign an informed consent form
Exclusion criteria
1. Patients with distant metastasis; 2. Patients with colon cancer; 3. Patients with a history of previous abdominal surgery; 4. ASA (American Society of Anesthesiologists) classification \> grade 3; 5. Patients who underwent emergency surgery; 6. Patients who underwent surgery ≤ 3 weeks from the last chemotherapy ; 7. Patients lost to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate of stoma | Day 30 after surgery | Observe and assess for stoma complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stoma DET（Discoloration，Erosion and Tissue overgrowth） score | Day 30 after surgery | Measure the state of the skin around the stoma and the corresponding lesion area, ranging from 0-15, higher scores mean a worse outcome of stoma |
| Stoma Pain Score | Day 30 after surgery | Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain |
| Quality of life scale score for patients with stoma | Day 30 after surgery | Measurement of quality of life for patients with stoma using City of Hope Quality of Life-Ostomy Questionnaire (CHO-QOL-OQ), ranging from 0-3200, higher scores mean a worse outcome of quality of life |
Countries
China
Outcome results
None listed