Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02847364
Other study ID # SUR.AMST.01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date December 2023

Study information

Verified date February 2022
Source American University of Beirut Medical Center
Contact Asdghig Der-Boghossian, LD, MS
Phone +961-1-350000
Email ahd14@mail.aub.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether chewing gum post-operatively decreases the time to first flatus or defecation in patients undergoing spine surgery as a indirect indicator of post-operative ileus.


Description:

The patients undergoing spine surgery are at risk of developing post-operative ileus, which will lengthen the hospital stay and cause gastrointestinal distress in patients. Post-operative sham feeding in form of chewing a gum seems to increase the functionality of gastro-intestinal tract earlier in patients who have undergone gastro-intestinal and gynecological surgeries. This study will recruit patients undergoing spine surgery at the investigators medical center and allocate them randomly into two equal groups. Patients in one group will be asked to chew gum after surgery and the other group will not be offered anything on chew on. Both groups will be kept nothing per os (NPO) otherwise till the first bowel movement. The first post-operative flatus and defecation time will be recorded as primary measures and other main outcomes will include first post-operative meal, length of stay and presence of ileus. The descriptive parameters of the two groups will also be recorded as related to relevant medical history, surgery, and post-operative care, to adjust for its effect on outcome measures. This study will identify any beneficial effect that chewing gum will have on post-operative ileus development and might be helpful in establishing better post-operative care protocols in patients undergoing spine surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility Inclusion Criteria: - Patient 13 years of age or older - Patients who will undergo spine decompression, laminectomy (cervical, lumbar and/or thoracic), discectomy, foraminotomy, or corpectomy, with or without arthrodesis, with or without instrumentation. Exclusion Criteria: - Less than 13 years of age - Patients who have undergone with abdominal surgery within the last month - Patients with inability or problems with chewing and/or dysphagia - Patients who are expected to be kept intubated after surgery - Patients who are allergic to any chewing gum component

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
chewing gum
The patient will chew one piece (1.45g) of regular chewing gum starting morning of post-operative day 1 for 30 minutes each time, three times per day, till the first bowel movement.

Locations

Country Name City State
Lebanon American University of Beirut Medical Center Beirut

Sponsors (1)

Lead Sponsor Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

References & Publications (4)

Fineberg SJ, Nandyala SV, Kurd MF, Marquez-Lara A, Noureldin M, Sankaranarayanan S, Patel AA, Oglesby M, Singh K. Incidence and risk factors for postoperative ileus following anterior, posterior, and circumferential lumbar fusion. Spine J. 2014 Aug 1;14(8):1680-5. doi: 10.1016/j.spinee.2013.10.015. Epub 2013 Oct 31. — View Citation

Jennings JK, Doyle JS, Gilbert SR, Conklin MJ, Khoury JG. The Use of Chewing Gum Postoperatively in Pediatric Scoliosis Patients Facilitates an Earlier Return to Normal Bowel Function. Spine Deform. 2015 May;3(3):263-266. doi: 10.1016/j.jspd.2014.12.001. Epub 2015 Apr 23. — View Citation

Short V, Herbert G, Perry R, Atkinson C, Ness AR, Penfold C, Thomas S, Andersen HK, Lewis SJ. Chewing gum for postoperative recovery of gastrointestinal function. Cochrane Database Syst Rev. 2015 Feb 20;(2):CD006506. doi: 10.1002/14651858.CD006506.pub3. Review. — View Citation

Zhu YP, Wang WJ, Zhang SL, Dai B, Ye DW. Effects of gum chewing on postoperative bowel motility after caesarean section: a meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):787-92. doi: 10.1111/1471-0528.12662. Epub 2014 Mar 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary first flatus time time of passing the first flatus after surgery; monitored for first flatus for up to 5 days after surgery. post-operative hospital stay till discharge (up to 5 days)
Primary first defecation time time of passing the first defecation after surgery, monitored for first defecation for up to 5 days after surgery. post-operative hospital stay till discharge (up to 5 days)
Secondary LOS the length of hospital stay (throughout their hospital stay, average of 5 days) hospital stay (average of 5 days)
Secondary Meal time The time of first tolerable meal after surgery; monitored for first tolerable meal for up to 5 days after surgery. post-operative hospital stay till discharge (up to 5 days)
Secondary post-operative ileus presence of post-operative ileus; monitored for ileus for up to 5 days after surgery. post-operative hospital stay till discharge (up to 5 days)
See also
  Status Clinical Trial Phase
Terminated NCT00065234 - Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus) Phase 2
Completed NCT01156129 - Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery Phase 1
Recruiting NCT05712525 - Gut Recovery In Patients Following Surgery
Completed NCT06338813 - Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus N/A
Recruiting NCT05315765 - Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
Completed NCT02161367 - Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery Phase 4
Completed NCT03711487 - The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection Phase 2
Completed NCT00528970 - A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair Phase 3
Not yet recruiting NCT04001985 - Nasogastric Tube Clamping Trial vs. Immediate Removal N/A
Completed NCT02836470 - A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection Phase 2
Completed NCT04100447 - A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection Phase 1
Active, not recruiting NCT03795467 - Peripheral Perfusion Index, Haemoglobin and Blood Transfusion in Acute Surgical Patients
Completed NCT01143259 - Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use N/A
Terminated NCT03352414 - Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC Phase 2
Not yet recruiting NCT04305730 - Use of Pedometer Following Radical Cystectomy N/A
Completed NCT02760290 - Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique N/A
Active, not recruiting NCT02399605 - Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus N/A
Completed NCT00388258 - Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus Phase 3
Terminated NCT05470387 - A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection Phase 3
Completed NCT00205842 - Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus Phase 3