跳至主要内容
临床试验/CTRI/2024/09/073979
CTRI/2024/09/073979招募中Phase 3 4

Effect of Peri-Operative Tibial Nerve Stimulation on Post Operative Paralytic Ileus in patient undergoing Colorectal surgery: An Observational Study.

All India Institute of Medical Sciences AIIMS1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年9月21日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
Passage of first flatus in the postoperative period

研究概览

简要总结

Aims and Objectives of the study:

Primary: To assess the efficacy of transcutaneous posterior tibial nerve stimulation in the recovery of bowel function

Secondary: To assess the safety and feasibility of posterior tibial nerve stimulation in a perioperative setting

InclusionandExclusion Criteria:

Inclusion Criteria-

  1. Age 18 – 75 Years of age
  2. Patient admitted to the Department of General Surgery and undergoing any Elective Laparoscopic / Open colorectal surgery – Resection and Anastomosis (Both Benign and Malignant)
  3. Patient undergoing stoma reversal (Hartman, End / loop colostomy)

ExclusionCriteria–

  1. Patient of Chronic Inflammatory bowel disease
  2. Patient with documented irritable bowel syndrome
  3. Surgical History of risk of damage to Vagal Nerve (Like Gastrectomy)
  4. Taking medication which will alter the metabolism of acetylcholine
  5. Patient with intact pacemaker
  6. Patient with diagnosed Peripheral Neuropathy

Methodology:

Study Design: Observational study

Study Period: 2024 to 2026

Sample size: 48

(Expected population standard deviation= 0.17

Employing t- distribution ot estimate sample size Confidence interval 95%

Precision = 0.05)

Reference: Dhand, NK. ,. & Khatkar, M.S. (2014). Statulator: An online statistical calculator Sample size calculator for estimating a single mean

Methods:

Recruitment: All the patients undergoing colorectal surgeries in the department of General Surgery, laparoscopic or open, All India Institute of Medical Sciences, Bhubaneswar.

Blinding: No

Intervention: Transcutaneous/ Percutaneous Tibial Nerve Stimulation

Procedure

Tibial nerve stimulation will be done using a nerve stimulator

Site - The generator will be connected to a transcutaneous, positive stick-on electrocardiograph-type electrode with foam backing placed over the posterior tibial nerve, immediately behind the malleolus where the tibial nerve is most superficial, and a ground

pad will be placed on the calf about 10 cm above, so as not to compromise a patient’s mobilization

Amplitude - 200 ms Pulse, frequency of 20 Hz, and amplitude 10 mA Duration - 20 Minutes

Timing - Stimulation the day before surgery once, 30 minutes Stimulation on the day of surgery, before surgery (at least 2 hours before surgery)

Stimulation every day thrice after surgery until gastrointestinal function recovery

PrimaryandSecondary Outcome:

Primary Outcome

  1. Time of passage of first flatus

Secondary Outcome

  1. Time of passage of stools and appearance of bowel sounds
  2. Length of postoperative hospital stay
  3. Episodes of vomiting
  4. Nasogastric tube (re)insertion
  5. Any complications related to the use of TTNS-Patch related allergy, burns from electrodes

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient admitted to the Department of General Surgery and undergoing any Elective Laparoscopic / Open colorectal surgery – Resection and Anastomosis (Both Benign and Malignant) 2.Patient undergoing stoma reversal (Hartman, End/loop colostomy).

排除标准

  • 1.Patients of Chronic inflammatory bowel disease 2.Patient with documented irritable bowel syndrome 3.Surgical History of risk of damage to Vagal Nerve (Like Gastrectomy) 4.Taking medication which will alter the metabolism of acetylcholine 5.Patient with an intact pacemaker 6.Patient with diagnosed Peripheral Neuropathy.

结局指标

主要结局

Passage of first flatus in the postoperative period

时间窗: in terms of post-operative days (e.g: day 1, day 2 etc. )

次要结局

  • 1.Time of passage of stools & appearance of bowel sounds(2.Length of postoperative hospital stay)

研究者

发起方
All India Institute of Medical Sciences AIIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ashok Kumar Sahoo

All India Institute of Medical Sciences (AIIMS)

研究点 (1)

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