Bariatric SurgeryNCT07569705
Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients
A study testing Transcutaneous nerve stimulator in people with Bariatric Surgery and Bariatric Surgery Candidate, run by Cairo University at 2 sites in Egypt.
Trial summary
Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bariatric Surgery, Bariatric Surgery Candidate
- What is being tested?
- Transcutaneous nerve stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 May 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index > 40 kg/m2
- ASA II
Who cannot join
- Limited diaphragmatic ultrasound views
- Patient with pulmonary diseases (COPD, bronchial asthma, and interstitial fibrosis)
- Patient refusal
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Cairo University Hospitals
Cairo
Mina Adolf Helmy, MD, 01275716942, minaadolf1988@cu.edu.eg
- Recruiting
Cairo University Hospitals
Cairo
Mina Adolf Helmy, MD, 01275716942, minaadolf1988@cu.edu.eg
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Controlled Trial
Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery
Read the detailed description
Bariatric surgery is associated with several postoperative consequences, including challenging pain control, respiratory complications, and diaphragmatic dysfunction. Postoperative diaphragmatic dysfunction is defined as a diaphragmatic excursion of less than 10 mm. There is substantial evidence that diaphragmatic ultrasound provides a reliable and accurate assessment of diaphragmatic function in both intensive care unit and perioperative settings.
The present randomized controlled trial aims to evaluate the influence of transcutaneous electrical nerve stimulation on postoperative diaphragmatic dysfunction in morbidly obese patients undergoing bariatric surgery.
- Conditions
- Bariatric Surgery, Bariatric Surgery Candidate
- Being tested
- Transcutaneous nerve stimulator, Sham TENS
- Keywords
- Bariatric, Diaphragmatic dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous nerve stimulatorDevice
The EM49 will be set to a TENS program with a frequency of 80-100 Hz and a pulse width of 200 μs
Sham TENSDevice
Electrodes will be placed identically, but no current will be delivered (sham TENS)
| Study group | Role | What they receive |
|---|---|---|
| TENS | Active comparator | Three times daily for the first postoperative day, each session will last 30 minutes Receives: Device: Transcutaneous nerve stimulator |
| Control | Sham comparator | Electrodes will be placed identically, but no current will be delivered (sham TENS) Receives: Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative diaphragmatic dysfunction
Diaphragmatic excursion < 10 mm 2 hours after surgery
Measured: 2 hours after surgery
Secondary outcomes (5)
Forced vital capacity (liters)
is the maximum volume of air that can forcibly exhaled after taking maximum breath
Measured: Before and at 2 and 24 hours postoperatively
Numeric rating scale
To quantify pain from 0 to 10 (with 10 indicates worst pain)
Measured: Within 24 hours after surgery
Nalbuphine consumption
Total postoperative nalbuphine consumption
Measured: 24 hours after surgery
Forced expiratory volume in one second (Liter)
Maximum volume of air can be exhaled in the first second after maximum inspiration
Measured: Before and at 2 and 24 hours
Peak expiratory flow rate (Liter/ second)
Maximum flow rate during forced expiration after maximum inhalation
Measured: Baseline, 2, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start17 May 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Application of transcutaneous electric nerve stimulator
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569705
- Sponsor's protocol ID
- TENS and PODD in bariatric
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon reasonable request to the corresponding author after publication of the primary results.
Publications
Tashani O, Johnson M. Transcutaneous Electrical Nerve Stimulation (TENS) A Possible Aid for Pain Relief in Developing Countries? Libyan J Med. 2009 Jun 1;4(2):62-5. doi: 10.4176/090119.
PubMed 21483510Helmy MA, Mostafa MS, Saber AT, Ali MA, Milad LM. Erector Spinae Plane Block and its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Double-Blind Randomized Control Trial. Obes Surg. 2025 Dec;35(12):5228-5236. doi: 10.1007/s11695-025-08337-y. Epub 2025 Nov 4.
PubMed 41188672Norskov J, Skaarup SH, Bendixen M, Tankisi H, Morkved AL, Juhl-Olsen P. Diaphragmatic dysfunction is associated with postoperative pulmonary complications and phrenic nerve paresis in patients undergoing thoracic surgery. J Anesth. 2024 Jun;38(3):386-397. doi: 10.1007/s00540-024-03325-5. Epub 2024 Mar 28.
PubMed 38546897Mostafa SF, Abdelghany MS, Abu Elyazed MM. Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Trial. Pain Pract. 2021 Apr;21(4):445-453. doi: 10.1111/papr.12975. Epub 2021 Jan 22.
PubMed 33295128
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07569705
- Acronym / sponsor ID
- TENS and PODD in bariatric
- Conditions
- Bariatric Surgery, Bariatric Surgery Candidate
- Keywords
- Bariatric, Diaphragmatic dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 May 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 May 2026 (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.
Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery
Detailed description
Bariatric surgery is associated with several postoperative consequences, including challenging pain control, respiratory complications, and diaphragmatic dysfunction. Postoperative diaphragmatic dysfunction is defined as a diaphragmatic excursion of less than 10 mm. There is substantial evidence that diaphragmatic ultrasound provides a reliable and accurate assessment of diaphragmatic function in both intensive care unit and perioperative settings.
The present randomized controlled trial aims to evaluate the influence of transcutaneous electrical nerve stimulation on postoperative diaphragmatic dysfunction in morbidly obese patients undergoing bariatric surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Application of transcutaneous electric nerve stimulator
| Arm | Type | Receives |
|---|---|---|
| TENS | Active comparator | Device: Transcutaneous nerve stimulatorThree times daily for the first postoperative day, each session will last 30 minutes |
| Control | Sham comparator | Device: Sham TENSElectrodes will be placed identically, but no current will be delivered (sham TENS) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index > 40 kg/m2
- ASA II
Key exclusion criteria (3 listed)
- Limited diaphragmatic ultrasound views
- Patient with pulmonary diseases (COPD, bronchial asthma, and interstitial fibrosis)
- Patient refusal
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 |
|---|---|---|
| Transcutaneous nerve stimulatorThe EM49 will be set to a TENS program with a frequency of 80-100 Hz and a pulse width of 200 μs | Device | TENS |
| Sham TENSElectrodes will be placed identically, but no current will be delivered (sham TENS) | Device | Control |
Primary outcome
Incidence of postoperative diaphragmatic dysfunction
Time frame: 2 hours after surgery
Diaphragmatic excursion < 10 mm 2 hours after surgery
5 secondary outcomes
Forced vital capacity (liters)
Time frame: Before and at 2 and 24 hours postoperatively
Numeric rating scale
Time frame: Within 24 hours after surgery
Nalbuphine consumption
Time frame: 24 hours after surgery
Forced expiratory volume in one second (Liter)
Time frame: Before and at 2 and 24 hours
Peak expiratory flow rate (Liter/ second)
Time frame: Baseline, 2, and 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 21483510Tashani O, Johnson M. Transcutaneous Electrical Nerve Stimulation (TENS) A Possible Aid for Pain Relief in Developing Countries? Libyan J Med. 2009 Jun 1;4(2):62-5. doi: 10.4176/090119.
- Results publication: PubMed 41188672Helmy MA, Mostafa MS, Saber AT, Ali MA, Milad LM. Erector Spinae Plane Block and its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Double-Blind Randomized Control Trial. Obes Surg. 2025 Dec;35(12):5228-5236. doi: 10.1007/s11695-025-08337-y. Epub 2025 Nov 4.
- Results publication: PubMed 38546897Norskov J, Skaarup SH, Bendixen M, Tankisi H, Morkved AL, Juhl-Olsen P. Diaphragmatic dysfunction is associated with postoperative pulmonary complications and phrenic nerve paresis in patients undergoing thoracic surgery. J Anesth. 2024 Jun;38(3):386-397. doi: 10.1007/s00540-024-03325-5. Epub 2024 Mar 28.
- Results publication: PubMed 33295128Mostafa SF, Abdelghany MS, Abu Elyazed MM. Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Trial. Pain Pract. 2021 Apr;21(4):445-453. doi: 10.1111/papr.12975. Epub 2021 Jan 22.
- Individual participant dataSharing planned: No. Data will be available upon reasonable request to the corresponding author after publication of the primary results.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous nerve stimulator in people with Bariatric Surgery and Bariatric Surgery Candidate, run by Cairo University at 2 sites in Egypt.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina Adolf Helmy, MD (01275716942, minaadolf1988@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative diaphragmatic dysfunction (time frame: 2 hours 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 NCT07569705, which also lists 4 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 20 May 2026.