Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02319512
Other study ID # 1818111
Secondary ID VGFOUGSB-1818111
Status Terminated
Phase Phase 3
First received December 7, 2014
Last updated December 13, 2014
Start date January 2012
Est. completion date December 2013

Study information

Verified date December 2014
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy.


Description:

Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer.

This study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.

Participants were included on the day of admission, which was the day prior to surgery. Randomization to the two groups (1:1) was done when patients returned from the intensive care unit (ICU) to the ward. This procedure was chosen in order to avoid perioperative drop-outs due to inoperable tumors. With a power of 80% and a level of significance of 0.05, 18 patients were needed in each group.Comparisons between the groups were analyzed with non-parametric tests; the Mann Whitney U test and Chi 2 test.

Controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum. The chewing gum used was ChiczaTM, a natural organic gum whose main ingredients are latex, glucose and natural flavors (lime or spearmint). Patients started to chew after they returned from the ICU the day after surgery. Chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay. The time to the first postoperative flatulence and defecation was recorded, in addition to standard clinical data.


Recruitment information / eligibility

Status Terminated
Enrollment 65
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.

- Understand and speak swedish

- No diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function

- No ongoing treatment for mental disease

- No ongoing abuse of alcohol or other drugs

- No previously known allergies to the content of chewing gum

Exclusion Criteria:

- Additional surgery after primary surgery.

- No radical curative surgery

- Previous abdominal surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Chewing gum
ChiczaTM organic chewing gum 6 pieces a day
Glucose
12ml glucose solution (13,6g) per day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Thomas Andersson

Outcome

Type Measure Description Time frame Safety issue
Primary First flatus after surgery From day of surgery until first postoperative flatus (with in the first 21 days) No
Primary First stool after surgery From day of surgery until first stool (with in the first 21 days) No
Secondary Start of clear fluids From day of surgery until start of clear liquids after surgery (with in the first 21 days) No
Secondary Start of liquid diet From day of surgery until start of liquid diet after surgery (with in the first 21 days) No
Secondary Length of hospital stay From day of surgery until discharge from surgical ward (with in the first 21 days) No
See also
  Status Clinical Trial Phase
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT02232893 - Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy Phase 2
Not yet recruiting NCT05001763 - Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy Phase 2
Active, not recruiting NCT04547868 - Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery N/A
Completed NCT02815956 - Tibial Nerve Stimulation and Postoperative Ileus N/A
Completed NCT02947269 - Prucalopride in Postoperative Ileus Phase 3
Recruiting NCT05512741 - Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
Recruiting NCT04675606 - Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies N/A
Completed NCT02161367 - Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery Phase 4
Completed NCT01956643 - Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation N/A
Completed NCT00464425 - Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery Phase 3
Completed NCT00402961 - Trial of Acupuncture for Reduction of Post-Colectomy Ileus Phase 2
Terminated NCT04100265 - ANTERO-5: Gastric Motility in Postoperative Ileus N/A
Recruiting NCT04090073 - Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery N/A
Recruiting NCT03222557 - Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer N/A
Withdrawn NCT02261454 - RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children N/A
Completed NCT02639728 - The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery. N/A
Completed NCT02004652 - Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery Phase 2
Completed NCT00509327 - Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery Phase 4
Completed NCT03097900 - Does Caffeine Enhance Bowel Recovery After Colorectal Surgery? Phase 2