Gastrointestinal SurgeryNCT03204344

Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

A study testing Oral carbohydrate (Outfast) and Routine fasting in people with Gastrointestinal Surgery, run by Dong-Xin Wang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate improves postoperative recovery. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Surgery
What is being tested?: Oral carbohydrate (Outfast) and Routine fasting
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteChina
Study dates: 1 Aug 2017to 7 Jun 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age of 18 years and beyond;
Diagnosed with type 2 diabetes before surgery;
Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more;
Provide signed writen informed consents.

Who cannot join

Refuse to participate in the study;
Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
Previous history of total or partial gastrectomy;
Preoperative New York Heart Assocition (NYHA) class IV, renal failure (requirement of renal replacement therapy), severe hepatic disease (Child-Pugh class C), or American Society of Anesthesiologists (ASA) class IV or higher;
Preoperative pyloric and/or intestinal obstruction;
Combined surgery on other intra-abdominal organs or other parts of the body.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial

Read the detailed description

Studies show that avoiding long-time fasting by oral carbohydrates 2 hours before surgery attenuates discomfort and anxiety; it also reduces stress, insulin resistance and catabolism in patients undergoing gastrointestinal surgery, resulting in earlier recovery of gastrointestinal function and short length of hospital stay after surgery. However, for diabetic patients scheduled to undergo gastrointestinal surgery, the risks and benefits of preopertive oral carbohydrate remain unclear. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

Conditions: Gastrointestinal Surgery
Being tested: Oral carbohydrate (Outfast), Routine fasting
Keywords: Gastrointestinal surgery, Preoperative oral carbohydrate, Diabetic patients, Postoperative recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral carbohydrate (Outfast)Dietary supplement
For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated by an endocrinologist according to patients' daily glucose controlling plan.
For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated is the same way as described above.
Routine fastingOther
For all patients, routine fasting (water drinking allowed) begin from 22:00 on the day before surgery until entering the operating room on the day of surgery.
For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added in the 5% glucose (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, and magnesium sulfate) are added when considered necessary.

Study groups in NCT03204344
Study group	Role	What they receive
Intervention group	Experimental	For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. Receives: Dietary Supplement: Oral carbohydrate (Outfast)
Control group	Sham comparator	For all patients, routine fasting (drinking water allowed) begins from 22:00 on the day before surgery， water fasting begins from 6:00 on the day of surgery. For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided from 6:00. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, magnesium sulfate) are added when becessary. Receives: Other: Routine fasting

What is being measured

The primary outcome is the main question the study is designed to answer.

Recovery of gastrointestinal function
Time to first flatus and defecation after surgery.
Measured: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.

Secondary outcomes (7)

Subjective feelings
Four subjective feelings, including the degree of being thirsty, hungry, tired and anxious, are assessed with Numeric Rating Scale (NRS, an 11-point scale where 0 = no feeling at all and 10 = the worst feeling).
Measured: Before anesthesia induction and at 4-6 hours after surgery.
Blood glucose variation
Difference between the highest and the lowest blood glucose levels.
Measured: From 22:00 on the day before surgery until 24 hours after surgery.
Insulin resistance (in part of patients)
Insulin resistance is calculated with the Homeostatic model assessment-insulin resistance (HOMA-IR) equation.
Measured: Assessed at 24 hours after surgery.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Measured: From end of surgery until hospital discharge, up to 30 days after surgery.
Incidence of postoperative complications
Postoperative complications are defined as newly occurred medical conditions that have harmful effects on patients' recovery and require therapeutic intervention.
Measured: From end of surgery until 30 days after surgery
Time to first walking in the ground and distance of walking after surgery.
Time to first walking in the ground and distance of walking after surgery.
Measured: During the first 5 days after surgery
All cause 30-day mortality
All cause 30-day mortality
Measured: At 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20177 Jun 2018

First posted2 Jul 2017
Study start1 Aug 2017
Primary completion7 May 2018
Study completion7 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Gastrointestinal SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03204344
Sponsor's protocol ID: 2017[1362]
Status last verified: Sep 2021
First submitted: 26 Jun 2017
Last updated: 9 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: IPD will be available by contacting Dr. Xue Li (lixuepku@hotmail.com) after the trial is completed.

Publications

Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27. doi: 10.1002/bjs.6963.
PubMed 20101593
Hausel J, Nygren J, Thorell A, Lagerkranser M, Ljungqvist O. Randomized clinical trial of the effects of oral preoperative carbohydrates on postoperative nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2005 Apr;92(4):415-21. doi: 10.1002/bjs.4901.
PubMed 15739210
Singh BN, Dahiya D, Bagaria D, Saini V, Kaman L, Kaje V, Vagadiya A, Sarin S, Edwards R, Attri V, Jain K. Effects of preoperative carbohydrates drinks on immediate postoperative outcome after day care laparoscopic cholecystectomy. Surg Endosc. 2015 Nov;29(11):3267-72. doi: 10.1007/s00464-015-4071-7. Epub 2015 Jan 22.
PubMed 25609319
Sada F, Krasniqi A, Hamza A, Gecaj-Gashi A, Bicaj B, Kavaja F. A randomized trial of preoperative oral carbohydrates in abdominal surgery. BMC Anesthesiol. 2014 Oct 17;14:93. doi: 10.1186/1471-2253-14-93. eCollection 2014.
PubMed 25364300
Helminen H, Viitanen H, Sajanti J. Effect of preoperative intravenous carbohydrate loading on preoperative discomfort in elective surgery patients. Eur J Anaesthesiol. 2009 Feb;26(2):123-7. doi: 10.1097/EJA.0b013e328319be16.
PubMed 19142085
Zelic M, Stimac D, Mendrila D, Tokmadzic VS, Fisic E, Uravic M, Sustic A. Influence of preoperative oral feeding on stress response after resection for colon cancer. Hepatogastroenterology. 2012 Jul-Aug;59(117):1385-9. doi: 10.5754/hge10556.
PubMed 22683955
Zelic M, Stimac D, Mendrila D, Tokmadzic VS, Fisic E, Uravic M, Sustic A. Preoperative oral feeding reduces stress response after laparoscopic cholecystectomy. Hepatogastroenterology. 2013 Oct;60(127):1602-6.
PubMed 24634929
Vigano J, Cereda E, Caccialanza R, Carini R, Cameletti B, Spampinato M, Dionigi P. Effects of preoperative oral carbohydrate supplementation on postoperative metabolic stress response of patients undergoing elective abdominal surgery. World J Surg. 2012 Aug;36(8):1738-43. doi: 10.1007/s00268-012-1590-4.
PubMed 22484570
Lidder P, Thomas S, Fleming S, Hosie K, Shaw S, Lewis S. A randomized placebo controlled trial of preoperative carbohydrate drinks and early postoperative nutritional supplement drinks in colorectal surgery. Colorectal Dis. 2013 Jun;15(6):737-45. doi: 10.1111/codi.12130.
PubMed 23406311
Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.
PubMed 21668975
Faria MS, de Aguilar-Nascimento JE, Pimenta OS, Alvarenga LC Jr, Dock-Nascimento DB, Slhessarenko N. Preoperative fasting of 2 hours minimizes insulin resistance and organic response to trauma after video-cholecystectomy: a randomized, controlled, clinical trial. World J Surg. 2009 Jun;33(6):1158-64. doi: 10.1007/s00268-009-0010-x.
PubMed 19363695
Makuuchi R, Sugisawa N, Kaji S, Hikage M, Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Enhanced recovery after surgery for gastric cancer and an assessment of preoperative carbohydrate loading. Eur J Surg Oncol. 2017 Jan;43(1):210-217. doi: 10.1016/j.ejso.2016.07.140. Epub 2016 Aug 10.
PubMed 27554250
Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.
PubMed 25121931
Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7.
PubMed 23200124
Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. doi: 10.1111/j.1463-1318.2006.00965.x.
PubMed 16919107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03204344
Acronym / sponsor ID: 2017[1362]
Conditions: Gastrointestinal Surgery
Keywords: Gastrointestinal surgery, Preoperative oral carbohydrate, Diabetic patients, Postoperative recovery
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Dong-Xin WangUniversity, hospital or other
Study start: 1 Aug 2017 (actual)
Primary completion: 7 May 2018 (actual)
Study completion: 7 Jun 2018 (actual)
First posted: 2 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.

Arm	Type	Receives
Intervention group	Experimental	Dietary Supplement: Oral carbohydrate (Outfast)For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking.
Control group	Sham comparator	Other: Routine fastingFor all patients, routine fasting (drinking water allowed) begins from 22:00 on the day before surgery， water fasting begins from 6:00 on the day of surgery. For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided from 6:00. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, magnesium sulfate) are added when becessary.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age of 18 years and beyond;
Diagnosed with type 2 diabetes before surgery;
Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more;
Provide signed writen informed consents.

Key exclusion criteria (6 listed)

Refuse to participate in the study;
Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
Previous history of total or partial gastrectomy;
Preoperative New York Heart Assocition (NYHA) class IV, renal failure (requirement of renal replacement therapy), severe hepatic disease (Child-Pugh class C), or American Society of Anesthesiologists (ASA) class IV or higher;
Preoperative pyloric and/or intestinal obstruction;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral carbohydrate (Outfast)For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated by an endocrinologist according to patients' daily glucose controlling plan. For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated is the same way as described above.	Dietary supplement	Intervention group
Routine fastingFor all patients, routine fasting (water drinking allowed) begin from 22:00 on the day before surgery until entering the operating room on the day of surgery. For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added in the 5% glucose (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, and magnesium sulfate) are added when considered necessary.	Other	Control group

Primary outcome

Recovery of gastrointestinal function
Time frame: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.
Time to first flatus and defecation after surgery.

7 secondary outcomes

Subjective feelings
Time frame: Before anesthesia induction and at 4-6 hours after surgery.
Blood glucose variation
Time frame: From 22:00 on the day before surgery until 24 hours after surgery.
Insulin resistance (in part of patients)
Time frame: Assessed at 24 hours after surgery.
Length of stay in hospital after surgery.
Time frame: From end of surgery until hospital discharge, up to 30 days after surgery.
Incidence of postoperative complications
Time frame: From end of surgery until 30 days after surgery
Time to first walking in the ground and distance of walking after surgery.
Time frame: During the first 5 days after surgery
All cause 30-day mortality
Time frame: At 30 days after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Background: PubMed 20101593Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27. doi: 10.1002/bjs.6963.
Background: PubMed 15739210Hausel J, Nygren J, Thorell A, Lagerkranser M, Ljungqvist O. Randomized clinical trial of the effects of oral preoperative carbohydrates on postoperative nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2005 Apr;92(4):415-21. doi: 10.1002/bjs.4901.
Background: PubMed 25609319Singh BN, Dahiya D, Bagaria D, Saini V, Kaman L, Kaje V, Vagadiya A, Sarin S, Edwards R, Attri V, Jain K. Effects of preoperative carbohydrates drinks on immediate postoperative outcome after day care laparoscopic cholecystectomy. Surg Endosc. 2015 Nov;29(11):3267-72. doi: 10.1007/s00464-015-4071-7. Epub 2015 Jan 22.
Background: PubMed 25364300Sada F, Krasniqi A, Hamza A, Gecaj-Gashi A, Bicaj B, Kavaja F. A randomized trial of preoperative oral carbohydrates in abdominal surgery. BMC Anesthesiol. 2014 Oct 17;14:93. doi: 10.1186/1471-2253-14-93. eCollection 2014.
Background: PubMed 19142085Helminen H, Viitanen H, Sajanti J. Effect of preoperative intravenous carbohydrate loading on preoperative discomfort in elective surgery patients. Eur J Anaesthesiol. 2009 Feb;26(2):123-7. doi: 10.1097/EJA.0b013e328319be16.
Background: PubMed 22683955Zelic M, Stimac D, Mendrila D, Tokmadzic VS, Fisic E, Uravic M, Sustic A. Influence of preoperative oral feeding on stress response after resection for colon cancer. Hepatogastroenterology. 2012 Jul-Aug;59(117):1385-9. doi: 10.5754/hge10556.
Background: PubMed 24634929Zelic M, Stimac D, Mendrila D, Tokmadzic VS, Fisic E, Uravic M, Sustic A. Preoperative oral feeding reduces stress response after laparoscopic cholecystectomy. Hepatogastroenterology. 2013 Oct;60(127):1602-6.
Background: PubMed 22484570Vigano J, Cereda E, Caccialanza R, Carini R, Cameletti B, Spampinato M, Dionigi P. Effects of preoperative oral carbohydrate supplementation on postoperative metabolic stress response of patients undergoing elective abdominal surgery. World J Surg. 2012 Aug;36(8):1738-43. doi: 10.1007/s00268-012-1590-4.
Background: PubMed 23406311Lidder P, Thomas S, Fleming S, Hosie K, Shaw S, Lewis S. A randomized placebo controlled trial of preoperative carbohydrate drinks and early postoperative nutritional supplement drinks in colorectal surgery. Colorectal Dis. 2013 Jun;15(6):737-45. doi: 10.1111/codi.12130.
Background: PubMed 21668975Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.
Background: PubMed 19363695Faria MS, de Aguilar-Nascimento JE, Pimenta OS, Alvarenga LC Jr, Dock-Nascimento DB, Slhessarenko N. Preoperative fasting of 2 hours minimizes insulin resistance and organic response to trauma after video-cholecystectomy: a randomized, controlled, clinical trial. World J Surg. 2009 Jun;33(6):1158-64. doi: 10.1007/s00268-009-0010-x.
Background: PubMed 27554250Makuuchi R, Sugisawa N, Kaji S, Hikage M, Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Enhanced recovery after surgery for gastric cancer and an assessment of preoperative carbohydrate loading. Eur J Surg Oncol. 2017 Jan;43(1):210-217. doi: 10.1016/j.ejso.2016.07.140. Epub 2016 Aug 10.
Individual participant dataSharing planned: Undecided. IPD will be available by contacting Dr. Xue Li (lixuepku@hotmail.com) after the trial is completed.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dong-Xin Wang, MD, PhD principal investigator

Peking University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oral carbohydrate (Outfast) and Routine fasting in people with Gastrointestinal Surgery, run by Dong-Xin Wang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery of gastrointestinal function (time frame: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03204344, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.