Lower Abdominal SurgeryNCT07102108
Effects of Anesthesia Techniques on Tissue Oxygenation and Recovery in Lower Abdominal Surgery
An observational study of Lower Abdominal Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
This is a prospective observational study designed to evaluate the effects of different anesthesia techniques on tissue oxygenation and postoperative recovery in patients undergoing lower abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 days
- Conditions the study is for
- Lower Abdominal Surgery
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Mar 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 to 80 days
- All sexes
- No healthy volunteers
- Child
Study population: Adult patients aged 18-80 undergoing elective lower abdominal surgeries under one of four anesthesia techniques (general, spinal, epidural, or combined general+epidural) at a single tertiary hospital. Patients with peripheral vascular disease, severe cardiopulmonary instability, or cognitive/communication limitations were excluded.
Who may be able to join
- Adults aged 18-80 years
- Scheduled for elective lower abdominal surgery
- Eligible for general, spinal, epidural or combined anesthesia techniques
- Provided writen informed consent
- ASA physical status 1-3
Who cannot join
- Refusal to participate
- Emergency surgery
- Severe cardiovascular or respiratory instability
- Pre-existing severe cognitive impairment of communication barrier
- Peripheral vascular disease affecting NIRS readind
- Local infection or anatomical anomaly preventing regional anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University, Faculty of Medicine
Edirne, Central, 22100
About this study
Official title: A Prospective Observational Study on the Effects of Anesthesia Techniques on Tissue Oxygenation and Postoperative Recovery in Lower Abdominal Surgery
This is a prospective observational study designed to evaluate the effects of different anesthesia techniques on tissue oxygenation and postoperative recovery in patients undergoing lower abdominal surgery. A total of 180 patients will be enrolled and evenly allocated into four groups based on the anesthesia method used: general anesthesia, spinal anesthesia, epidural anesthesia, and combined general plus epidural anesthesia.
Near-infrared spectroscopy (NIRS) will be utilised to monitor tissue oxygenation at the thenar and plantar regions during the perioperative period. Vital signs, VAS scores(min 0-max 10 points), Quality of Recovery-40 (QoR-40) scores(min 40-max 200 points), and additional postoperative recovery parameters- including length of stay in the post-anesthesia care unit and hospital, surgical site infection, wound revision, and mortality- will be recorded and compared across the groups.
The primary hypothesis is that regional anesthesia techniques enchance tissue oxygenation and are associated with improved postoperative recovery outcomes compared to general anesthesia alone. The study was approved by the local ethics committee and will be conducted at a single tertiary-care center.
- Conditions
- Lower Abdominal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Patient receiving general anesthesia only for lower abdominal surgery | |
| General+Epidural Anesthesia | Patient receiving combined general and epidural anesthesia for lower abdominal surgery | |
| Spinal | Patient receiving spinal anesthesia only for lower abdominal surgery | |
| Epidural Anesthesia | Patient receiving epidural anesthesia only for lower abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Oxygenation Levels Measured by NIRS
Continuous measurement of tissue oxygenation at thenar and plantar sites using near-infrared spectroscopy during perioperative period
Measured: From baseline(pre-op) to end of surgery
Secondary outcomes (6)
Intraoperative Vital Signs
Systolic blood pressure recorded during anesthesia
Measured: Intraoperative period
Intraoperative Vital Signs
Diastolic blood pressure recorded during anesthesia
Measured: Intraoperative period
Intraoperative Vital Signs
Heart rate recorded during anesthesia
Measured: Intraoperative period
Intraoperative Vital Signs
Oxygenation saturation recorded during anesthesia
Measured: Intraoperative period
Visual Analog Scale(VAS) Pain Scores
VAS pain scores measured postoperatively at PACU and postoperative day 1. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse outcomes.
Measured: Up to 24 hours after surgery
Qor-40 Questionnaire Scores
Quality of Recovery scores assessed using the Qor-40 questionnaire on postoperative day1. The total score ranges from 40 to 200, with higher scores indicating better recovery.
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Mar 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Abdominal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ars Gor Dr Edip Gules, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102108
- Sponsor's protocol ID
- TUTF-GOBAEK 2023-25
- Other IDs
- TUTF-GOBAEK 2023-25
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Effects of Anesthesia Techniques on Tissue Oxygenation and Postoperative Recovery in Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07102108
- Acronym / sponsor ID
- TUTF-GOBAEK 2023-25
- Conditions
- Lower Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 3 Aug 2025 (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.
This is a prospective observational study designed to evaluate the effects of different anesthesia techniques on tissue oxygenation and postoperative recovery in patients undergoing lower abdominal surgery. A total of 180 patients will be enrolled and evenly allocated into four groups based on the anesthesia method used: general anesthesia, spinal anesthesia, epidural anesthesia, and combined general plus epidural anesthesia.
Near-infrared spectroscopy (NIRS) will be utilised to monitor tissue oxygenation at the thenar and plantar regions during the perioperative period. Vital signs, VAS scores(min 0-max 10 points), Quality of Recovery-40 (QoR-40) scores(min 40-max 200 points), and additional postoperative recovery parameters- including length of stay in the post-anesthesia care unit and hospital, surgical site infection, wound revision, and mortality- will be recorded and compared across the groups.
The primary hypothesis is that regional anesthesia techniques enchance tissue oxygenation and are associated with improved postoperative recovery outcomes compared to general anesthesia alone. The study was approved by the local ethics committee and will be conducted at a single tertiary-care center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | –Patient receiving general anesthesia only for lower abdominal surgery |
| General+Epidural Anesthesia | – | –Patient receiving combined general and epidural anesthesia for lower abdominal surgery |
| Spinal | – | –Patient receiving spinal anesthesia only for lower abdominal surgery |
| Epidural Anesthesia | – | –Patient receiving epidural anesthesia only for lower abdominal surgery |
Who may qualify
- Ages
- 18 to 80 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adult patients aged 18-80 undergoing elective lower abdominal surgeries under one of four anesthesia techniques (general, spinal, epidural, or combined general+epidural) at a single tertiary hospital. Patients with peripheral vascular disease, severe cardiopulmonary instability, or cognitive/communication limitations were excluded.
Key inclusion criteria (5 listed)
- Adults aged 18-80 years
- Scheduled for elective lower abdominal surgery
- Eligible for general, spinal, epidural or combined anesthesia techniques
- Provided writen informed consent
- ASA physical status 1-3
Key exclusion criteria (6 listed)
- Refusal to participate
- Emergency surgery
- Severe cardiovascular or respiratory instability
- Pre-existing severe cognitive impairment of communication barrier
- Peripheral vascular disease affecting NIRS readind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue Oxygenation Levels Measured by NIRS
Time frame: From baseline(pre-op) to end of surgery
Continuous measurement of tissue oxygenation at thenar and plantar sites using near-infrared spectroscopy during perioperative period
6 secondary outcomes
Intraoperative Vital Signs
Time frame: Intraoperative period
Intraoperative Vital Signs
Time frame: Intraoperative period
Intraoperative Vital Signs
Time frame: Intraoperative period
Intraoperative Vital Signs
Time frame: Intraoperative period
Visual Analog Scale(VAS) Pain Scores
Time frame: Up to 24 hours after surgery
Qor-40 Questionnaire Scores
Time frame: postoperative day 1
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 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Lower Abdominal Surgery
Recruiting
Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries
Bilateral Inguinal Hernia Repair, Open Upper Abdominal Surgeries
RecruitingPhase 4
Dexamethasone and Duration of Spinal Anesthesia
Dexamethasone, Spinal Anesthesia
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
RecruitingObservational study
Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years
Agitation, Postoperative Agitation
RecruitingPhase 1/2
Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain
Acue Postoperative Pain
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?
An observational study of Lower Abdominal Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
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 5 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 3 Aug 2025. 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 Turkey (Türkiye). 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?
Tissue Oxygenation Levels Measured by NIRS (time frame: From baseline(pre-op) to end of surgery). 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 3 Aug 2025.