Perforated Duodenal UlcerNCT04431037
Early Oral Feeding vs Traditional Post-operative Care In Emergency Abdominal Surgeries
A study testing Early oral feeding/Enhanced recovery after surgery protocols in people with Perforated Duodenal Ulcer, run by College of Physicians and Surgeons Pakistan at 1 site in Pakistan.
Trial summary
ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely studied in elective abdominal surgeries and have shown better outcomes. However the utility of these protocols in emergency abdominal surgeries has not been widely investigated. Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Perforated Duodenal Ulcer
- What is being tested?
- Early oral feeding/Enhanced recovery after surgery protocols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Aug 2018to 27 Dec 2019
- 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 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients older than 15 years with acute abdominal symptoms admitted in ER department, suspected as perforated duodenal ulcer and operated within 24 hours of admission by emergency department surgeon.
Who cannot join
- Patients presenting with the following criteria were excluded:
- Refusal to join the study
- Peptic ulcers with both bleeding and perforation.
- Spontaneously sealed off perforations.
- Malignant ulcers
- Concurrent extra-abdominal surgery
Show all 10Show fewer
- Oral incapacity i.e endotracheal intubation
- Reoperation within a month
- ASA grade III/IV
- Alternative per operative diagnosis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Surgical Unit I,Benazir Bhutto Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: EARLY ORAL FEEDING VS TRADITIONAL POST-OPERATIVE CARE IN PATIENTS UNDERGOING EMERGENCY ABDOMINAL SURGERY FOR PERFORATED DUODENAL ULCER(Emergency Abdominal Surgeries)
ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely studied in elective abdominal surgeries and have shown better outcomes. However the utility of these protocols in emergency abdominal surgeries has not been widely investigated.
OBJECTIVE: To study the outcomes of application of ERAS protocols in patients undergoing perforated duodenal ulcers repairs in emergency abdominal surgeries.
Read more
METHODS: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.
KEY WORDS: Perforated duodenal ulcer, ERAS protocol, randomized controlled trial, duodenal repair site leak, length of hospital stay, VAS score, post-operative ileus
- Conditions
- Perforated Duodenal Ulcer
- Being tested
- Early oral feeding/Enhanced recovery after surgery protocols
- Keywords
- Perforated duodenal ulcer, Enhanced Recovery After Surgery (ERAS) protocol, Randomized controlled trial, Duodenal repair site leak, Length of hospital stay, Visual analog score, Post-operative ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral feeding/Enhanced recovery after surgery protocolsDietary supplement
Early oral feeding refers to NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.
| Study group | Role | What they receive |
|---|---|---|
| Early oral feeding group(A) | Experimental | Patients admitted in the HDU postoperatively.NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD. Receives: Dietary Supplement: Early oral feeding/Enhanced recovery after surgery protocols |
| Traditional postoperative care group(B) | No intervention | Patients in this group were managed traditionally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay is defined as duration of single episode of hospitalization. Inpatient days are calculated by subtracting day of admission from day of discharge
Measured: upto 10 Days
DAYS OF RETURN OF BOWEL FUNCTION.
It is defined as time to passage of flatus or stools after abdominal surgery.
Measured: Upto 24 hours
Pain score by Visual Analog Scale
Pain is defined as "an unpleasant sensory and emotional experience that is associated with actual or potential tissue damage or described in such terms" according to International Association for the Study of Pain,measured by Visual Analog Scale(VAS).
Measured: upto 36 hours
Secondary outcomes (2)
Bleeding peptic ulcer
Frequency of bleeding peptic ulcer
Measured: intraoperative period
Mortality rate
Estimation of mortality rate associated with perforated duodenal ulcer
Measured: immediate postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start13 Aug 2018
- Primary completion30 Oct 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated Duodenal UlcerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Masood, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431037
- Sponsor's protocol ID
- pdu
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on request.Only that described in the text of full article.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY ORAL FEEDING VS TRADITIONAL POST-OPERATIVE CARE IN PATIENTS UNDERGOING EMERGENCY ABDOMINAL SURGERY FOR PERFORATED DUODENAL ULCER(Emergency Abdominal Surgeries)
- ClinicalTrials.gov ID
- NCT04431037
- Acronym / sponsor ID
- pdu
- Conditions
- Perforated Duodenal Ulcer
- Keywords
- Perforated duodenal ulcer, Enhanced Recovery After Surgery (ERAS) protocol, Randomized controlled trial, Duodenal repair site leak, Length of hospital stay, Visual analog score, Post-operative ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 16 Jun 2020 (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.
ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely studied in elective abdominal surgeries and have shown better outcomes. However the utility of these protocols in emergency abdominal surgeries has not been widely investigated.
OBJECTIVE: To study the outcomes of application of ERAS protocols in patients undergoing perforated duodenal ulcers repairs in emergency abdominal surgeries.
METHODS: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.
KEY WORDS: Perforated duodenal ulcer, ERAS protocol, randomized controlled trial, duodenal repair site leak, length of hospital stay, VAS score, post-operative ileus
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.
| Arm | Type | Receives |
|---|---|---|
| Early oral feeding group(A) | Experimental | Dietary Supplement: Early oral feeding/Enhanced recovery after surgery protocolsPatients admitted in the HDU postoperatively.NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD. |
| Traditional postoperative care group(B) | No intervention | –Patients in this group were managed traditionally |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients older than 15 years with acute abdominal symptoms admitted in ER department, suspected as perforated duodenal ulcer and operated within 24 hours of admission by emergency department surgeon.
Key exclusion criteria (10 listed)
- Patients presenting with the following criteria were excluded:
- Refusal to join the study
- Peptic ulcers with both bleeding and perforation.
- Spontaneously sealed off perforations.
- Malignant ulcers
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 |
|---|---|---|
| Early oral feeding/Enhanced recovery after surgery protocolsEarly oral feeding refers to NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD. | Dietary supplement | Early oral feeding group(A) |
Primary outcome
Length of hospital stay
Time frame: upto 10 Days
Length of hospital stay is defined as duration of single episode of hospitalization. Inpatient days are calculated by subtracting day of admission from day of discharge
DAYS OF RETURN OF BOWEL FUNCTION.
Time frame: Upto 24 hours
It is defined as time to passage of flatus or stools after abdominal surgery.
Pain score by Visual Analog Scale
Time frame: upto 36 hours
Pain is defined as "an unpleasant sensory and emotional experience that is associated with actual or potential tissue damage or described in such terms" according to International Association for the Study of Pain,measured by Visual Analog Scale(VAS).
2 secondary outcomes
Bleeding peptic ulcer
Time frame: intraoperative period
Mortality rate
Time frame: immediate postoperative period
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 16 Jun 2020.
- Individual participant dataSharing planned: No. Data can be shared on request.Only that described in the text of full article.
Related trials for Perforated Duodenal Ulcer
Not yet recruiting
Comparison of Open vs Laparoscopic Repair of Perforated Duodenal Ulcer
Perforated Duodenal Ulcer
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
RecruitingObservational study
Prevention of Postoperative Hernias in Emergency Surgery
Incarcerated Hernia, Appendicitis Acute
Not yet recruiting
Falciformopexy for Treatment Perforated Peptic Ulcer.
Perforated Peptic Ulcer
RecruitingObservational study
Web-based International Register of Emergency Surgery and Trauma
Acute Appendicitis, Acute Cholecystitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early oral feeding/Enhanced recovery after surgery protocols in people with Perforated Duodenal Ulcer, run by College of Physicians and Surgeons Pakistan at 1 site in Pakistan.
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 1 inclusion and 10 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 16 Jun 2020. 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 Pakistan. 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. 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?
Length of hospital stay (time frame: upto 10 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2020.