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Completed

NCT Number: NCT02433938

Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery

Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the enhancement of the recovery of bowel function and in shortening the hospital stay.

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Key information

Conditions

Postoperative Ileus Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients were randomized in two groups. The first group underwent a three days postoperative transcutaneous tibial nerve stimulation. The second group underwent a sham stimulation. Aim of the study is to evaluate the role of tibial nerve stimulation in the postoperative recovery after colorectal surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients that underwent colorectal surgery

Exclusion criteria

  • Severe comorbidities
  • Postoperative or intraoperative complications

Treatment and study plan

Tibial nerve stimulation

Procedure

patients underwent a three days postoperative transcutaneous tibial nerve stimulation

Sham tibial nerve stimulation

Procedure

patients did not undergo a postoperative transcutaneous tibial nerve stimulation

Primary outcomes

  1. bowel function recovery (Time to first bowel movement or flatus)

    Time frame: 7 days

    Time to first bowel movement or flatus

Secondary outcomes

  1. Length of postoperative hospital stay

    Time frame: 30 days

    Length of postoperative hospital stay

  2. Post-operative vomiting (episodes of vomiting)

    Time frame: 30 days

    Episodes of vomiting

  3. Use of NG Tubes (Nasogastric tube (re)insertions)

    Time frame: 30 days

    Nasogastric tube (re)insertions

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Acronym: TiRex

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 5, 2015
Registry last updated
Oct 2, 2018

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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