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Completed

NCT Number: NCT06010043

"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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 3.
  • Patient participate voluntarily and sign an informed consent form

Exclusion criteria

  • 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.

Treatment and study plan

Suturing of ileostomy using "Dumpling suture method"

Procedure

Suturing of ileostomy using "Dumpling suture method"

Suturing of ileostomy using Traditional suture method

Procedure

Suturing of ileostomy using Traditional suture method

Primary outcomes

  1. Complication rate of stoma

    Time frame: Day 30 after surgery

    Observe and assess for stoma complications

Secondary outcomes

  1. Stoma DET(Discoloration,Erosion and Tissue overgrowth) score

    Time frame: 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

  2. Stoma Pain Score

    Time frame: 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

  3. Quality of life scale score for patients with stoma

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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