跳至主要内容
临床试验/NCT06010043
NCT06010043已完成不适用

"Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Complication rate of stoma

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients underwent successful laparoscopic anterior rectal resection plus protective loop ileostomy with specimen extraction through stoma incision;
  • •All patients were pathologically diagnosed with rectal carcinoma or ulcerative colitis;
  • •Patients aged 18 - 80 years
  • •ASA (American Society of Anesthesiologists) classification ≤ grade
  • •Patient participate voluntarily and sign an informed consent form

排除标准

  • •Patients with distant metastasis;
  • •Patients with colon cancer;
  • •Patients with a history of previous abdominal surgery;
  • •ASA (American Society of Anesthesiologists) classification > grade 3;
  • •Patients who underwent emergency surgery;
  • •Patients who underwent surgery ≤ 3 weeks from the last chemotherapy ;
  • •Patients lost to follow-up.

研究组 & 干预措施

"Dumpling suture" for ileostomy

Experimental

The stoma is fixed with sutures in a skin fold method, and the incision is progressively reduced in a process similar to the process of folding and pinching the Chinese small dumplings. This procedure may reduce stoma complications by progressively reducing the incision and realizing the effect of hiding the skin incision.

干预措施: Suturing of ileostomy using "Dumpling suture method" (Procedure)

Traditional suture for ileostomy

Other

The stoma was fixed at the skin using traditional sutures. The incision is narrowed by 2-3 interrupted sutures at the distal and proximal ends of the skin incision on the abdominal wall. The stoma is then fixed at the right lower abdominal incision with sutures.

干预措施: Suturing of ileostomy using Traditional suture method (Procedure)

结局指标

主要结局

Complication rate of stoma

时间窗: Day 30 after surgery

Observe and assess for stoma complications

次要结局

  • Stoma Pain Score(Day 30 after surgery)
  • Stoma DET(Discoloration,Erosion and Tissue overgrowth) score(Day 30 after surgery)
  • Quality of life scale score for patients with stoma(Day 30 after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tingyu Wu

Principal Investigator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

Loading locations...

相似试验

已完成
不适用
A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via StomaComplications Ileostomy
NCT05985499Xinhua Hospital, Shanghai Jiao Tong University School of Medicine72
已完成
不适用
Staple vs. Suture in Robotic ProstatectomyProstate Cancer
NCT03480074Swedish Medical Center300
已完成
不适用
Comparison of Innovative Suture with Conventional Suture on Severity of Complications Following Mandibular fully Impacted third molar SurgeryCondition 1: Mandibular fully impacted third molar surgery. Condition 2: Postoperative facial swelling after mandibular fully impacted third molar surgery. Condition 3: Trismus after mandibular fully impacted third molar surgery. Condition 4: Dehiscence after mandibular fully impacted third molar surgery. Condition 5: Dry socket after mandibular fully impacted third molar surgery.Impacted teethLocalized swelling, mass and lump, unspecifiedSprain of jawDisruption of external operation (surgical) wound, not elsewhere classifiedAlveolitis of jawsT81.31
IRCT20181021041404N1Research center of Semnan Dental School40
Unknown
不适用
Peritoneum and Anterior Rectus Sheath Suturing and IleostomyRectal NeoplasmsIleostomy - Stoma
NCT06344923Qilu Hospital of Shandong University120
已完成
不适用
Natural Orifice Specimen Extraction in Sigmoid VolvulusMortalityMorbidity
NCT04740619Dr. Ersin Arslan Education and Training Hospital8